Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03154268

Acronym

GWGCPW

Enrollment

10422

Registered

2017-05-16

Start date

2015-01-31

Completion date

2017-03-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Weight Gain

Keywords

Gestational weight gain, Chinese pregnant women, Retrospective longitudinal study, China, IOM guideline, Adverse outcome, Model

Brief summary

The purpose of this study is to investigate the reference ranges and rates of gestational weight gain among Chinese pregnant women, and to analyze the correlation between gestational weight gain and adverse outcomes.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

1. Deliveries between January 2013 and December 2014; 2. Gestational age between 37 weeks or older and less than 42 weeks; 3. Registration with care documents at the first prenatal visit prior to the 15th gestational week; 4. Had at least five follow-up visits until delivery.

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
Preeclampsia	After 20th gestational weeks till delivery, about 5 months	Maternal systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg during gestation. Urine protein ≥5.0 g within 24h, urine volume \<400 mL. HELLP syndrome or pulmonary edema present.
Eclampsia	After 20th gestational weeks till delivery, about 5 months	Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
ICP	After 14th gestational weeks till delivery, about 6 months	Intrahepatic cholestasis of pregnancy.
Placenta previa	During pregnancy till delivery	Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
Gestational diabetes	After 24th gestational weeks, about 4 months	By oral glucose tolerance test between 24th and 28th gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).
Ruptured uterus	During delivery	Rupture of maternal uterus confirmed by laparotomy.
Placental abruption	After 20th gestational weeks till delivery, about 5 months	Abruption of a normally positioned placenta before delivery, diagnosed by clinical symptoms, ultrasound, fetal heart monitoring, or laboratory tests.
Postpartum hemorrhage	Within 24h after delivery	Postpartum bleeding volume ≥500 mL.
Hepatic diseases	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Hepatitis-B/C/E virus infection, acute fatty liver disease, or severe hepatitis.
Hematological diseases	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Iron-deficiency anemia, thalassemia, hemophilia, idiopathic thrombocytopenic purpura, aplastic anemia, or disseminated intravascular coagulation.
Gynecological diseases	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Uterine fibroids, ovarian cyst, cervical carcinoma, pelvic inflammation, or ovarian carcinoma.
Respiratory diseases	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Pneumonia, bronchitis, asthma or pulmonary tuberculosis.
Thyroid disease	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Hyperthyroidism or hypothyroidism.
ICU admission	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Admission to intensive care unit.
Maternal death	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	Maternal death.
Macrosomia	within 1 month after delivery	Birth weight \>4000 g.
Infant of low-birth weight	within 1 month after delivery	Birth weight \<2500 g.
Neonatal ICU admission	Within 1 month after delivery	Admission to neonatal intensive care unit.
Neonatal death	Within 1 month after delivery	Neonatal death.
Large for gestational age	Within 1 month after delivery	Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.
Small for gestational age	Within 1 month after delivery	Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.
Neonatal defect	Within 1 month after delivery	Neonatal defect.
Maternal adverse outcomes	During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year	There occurred one or more of preeclampsia, eclampsia, ICP, placenta previa, gestational diabetes, ruptured uterus, placental abruption, postpartum hemorrhage, hepatic diseases, hematological diseases, gynecological diseases, respiratory diseases, thyroid disease, ICU admission, or maternal death.
Neonatal adverse outcomes	Within 1 month after delivery	There occurred one or more of macrosomia, low-birth weight, neonatal ICU admission, neonatal death, large for gestational age, small for gestational age, or neonatal defect.

Outcome results